Navigation Links
Statement from the Cystic Fibrosis Foundation on Passage of the EXPERRT Act in House of Representatives
Date:6/20/2012

BETHESDA, Md., June 20, 2012 /PRNewswire-USNewswire/ -- The Cystic Fibrosis Foundation issued the following statement in response to passage of legislation today in the House of Representatives to expand consultation between the Food and Drug Administration (FDA) and external rare disease experts and patient advocates during the FDA drug approval process. 

The bill is known as the Expanding and Promoting Expertise in Review of Rare Treatments Act (EXPERRT). It was introduced by Reps. Edward Markey (D-MA), Tom Marino (R-PA) and Cliff Stearns (R-FL).  EXPERRT passed as part of the Food and Drug Administration Safety and Innovation Act, which reauthorizes the FDA's user-fee program that funds its drug and device evaluation.

"The Cystic Fibrosis Foundation applauds the approval of the EXPERRT Act, which will help expedite the approval of safe and effective new rare-disease drugs and treatments for patients by ensuring that the FDA has the most complete information during its evaluation," said Robert J. Beall, Ph.D., president and CEO of the Cystic Fibrosis Foundation. "This legislation is critically important to the 30,000 Americans with cystic fibrosis and millions more with rare diseases who desperately need access to sophisticated therapies for their complex conditions. We extend our special thanks to Representatives Markey, Marino and Stearns for the critical work they have done to advance this legislation."

"The inclusion of the EXPERRT Act in the FDA Safety and Innovation Act ensures that sharing knowledge amongst the FDA and individuals with expertise in rare diseases will become common practice," said Markey, co-chair of the Congressional Cystic Fibrosis Caucus. "Information about the severity of diseases, the risks patients may be willing to take, or improved clinical trial designs will help facilitate the review process and bring new treatments for rare diseases like cystic fibrosis to market quicker and more easily."'/>"/>

SOURCE Cystic Fibrosis Foundation
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Millennium Laboratories Wins Lawsuit: Ameritox Advertisements Regarding Rx Guardian and Rx Guardian CD Contain Literally False Statements
2. American Society of Hematology Statement on House Passage of Prescription Drug User Fee Act (PDUFA)
3. American Society of Hematology Statement on Senate Passage of Prescription Drug User Fee Act (PDUFA)
4. Icahn Issues Statement Regarding Amylin Pharmaceuticals
5. Savara Pharmaceuticals Completes Phase I Clinical Study of AeroVanc in Cystic Fibrosis Patients
6. Top-line Data From Phase 3 Trial of Ataluren in Patients with Nonsense Mutation Cystic Fibrosis Show Promising Results
7. Insmed Incorporated Announces Lifting of Clinical Hold by U.S. Food and Drug Administration on ARIKACE® in Cystic Fibrosis Patients With Pseudomonas Lung Infections
8. Synteract and Rempex Partner in "Great Strides" Walk to Support Cystic Fibrosis Cure
9. Cell Therapeutics to Host Investor and Analyst Meeting to Discuss Targeted Agents in Myelofibrosis and High-Risk Myelodysplastic Syndrome/Acute Myeloid Leukemia on Sunday, June 3, 2012, in Chicago
10. Gateway Foundation Warns K2 is Bad News: K2 Poses Serious Health Risks
11. AUA Foundation Launches Campaign to Address Stigma of Overactive Bladder
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/31/2015)... Ore., July 31, 2015  Semler Scientific, Inc. (Nasdaq: ... testing services to healthcare insurers and physician groups, today ... 30, 2015. "In the second quarter ... year revenue growth of 54%, quarter over quarter revenue ... the installed base of FloChec® units of 18%," said ...
(Date:7/30/2015)... July 30, 2015 Edwards Lifesciences Corporation (NYSE: ... valves and hemodynamic monitoring, today announced that Robert A. ... "Bob is an ardent champion for innovation in ... to have him on Edwards, board as we pursue our ... chairman and CEO.  "Bob has provided a valuable perspective to ...
(Date:7/30/2015)... 2015  Tandem Diabetes Care®, Inc. (NASDAQ: ... of the t:slim® and t:flex™ Insulin Pumps, today ... Agreements with Dexcom, Inc. to allow the integration ... Dexcom G5 and G6 continuous glucose monitoring ("CGM") ... platform with Dexcom,s future CGM systems is an ...
Breaking Medicine Technology:Semler Reports Second Quarter 2015 Financial Results 2Semler Reports Second Quarter 2015 Financial Results 3Semler Reports Second Quarter 2015 Financial Results 4Semler Reports Second Quarter 2015 Financial Results 5Semler Reports Second Quarter 2015 Financial Results 6Tandem Diabetes Care Announces Development Agreement with Dexcom for Integration of Future Generation CGM Systems 2Tandem Diabetes Care Announces Development Agreement with Dexcom for Integration of Future Generation CGM Systems 3
... Ankle sprains are a ... , Approximately 40 ... even after being treated for their initial injury. , , ... 2009 issue of the Journal of the American Academy of Orthopaedic ...
... ePharmaSolutions, a leading provider of clinical services and ... it has been selected along with its client Genentech, ... Practice Award for it,s Clinical Trial Portal solution. ... by a peer reviewed panel of 14 expert judges. ...
Cached Medicine Technology:Chronic Ankle Pain May Be More Than Just a Sprain 2Chronic Ankle Pain May Be More Than Just a Sprain 3ePharmaSolutions' Clinical Trial Investigator Portal Wins Bio-IT World 2009 Best Practice Award 2
(Date:7/31/2015)... New York (PRWEB) , ... July 31, 2015 , ... ... strut their stuff, Super-Sod debuted their new type of sod called Leisure Time(TM) ... trademark application in process. , To commemorate introduction of this new type of sod, ...
(Date:7/31/2015)... ... ... Ticket Down is a reliable source for authentic tickets for the 2015 ... The festival will end on Sunday, August 2nd. , Music fans have ... This unique and unbelievably popular festival attracts the best in entertainment from around the ...
(Date:7/31/2015)... (PRWEB) , ... July 31, 2015 , ... ... its new store run by GoodThreads. The store can be accessed by visiting ... designs, many of which are customizable. The best part: whenever a product is ...
(Date:7/31/2015)... , ... July 31, 2015 , ... There’s no better ... even when it comes time to cook the next meal, making July the most ... by practicing best grilling tips and recipes. , Make the next cookout different than ...
(Date:7/31/2015)... CA (PRWEB) , ... July 31, 2015 , ... Coco ... the athletes, judges, media, and VIPs at the 2015 Vans US Open of Surfing, ... coconut water that can claim “no added sugar” on the market, is a natural ...
Breaking Medicine News(10 mins):Health News:Super-Sod Introduces Leisure Time(TM) Zoysia Grass with an Adirondack Chair Promotion 2Health News:Cheap 2015 Lollapalooza Tickets: Ticket Down Slashes Ticket Prices on Lollapalooza Tickets at Grant Park in Chicago for Saturday, August 1st and Sunday, August 2nd 2Health News:Mesothelioma Organization Launches New Store 2Health News:Mesothelioma Organization Launches New Store 3Health News:King Kullen Honors National Hot Dog and Blueberry Month 2Health News:King Kullen Honors National Hot Dog and Blueberry Month 3Health News:Coco Libre Brings Eco-conscious Hydration to Vans US Open of Surfing 2
... ... released a secure softphone for Windows called GuardVox Phone with support for the ZRTP protocol, ... ... Corporation, a leading Japanese VoIP software company, has released a secure softphone for Windows called ...
... Why is there so much disagreement about whether using ... psychology study shows that the debate about drugs might ... competing theories. One theory -- the conventional ... primarily coming from people,s political ideology, level of religious ...
... Widespread geographic variations exist in drug spending among Medicare beneficiaries, ... to a University of Pittsburgh Graduate School of Public Health ... the New England Journal of Medicine , and the ... also found that higher spending on drugs was not balanced ...
... ... found that untreated tooth decay in mothers almost doubled the odds of tooth decay in ... children, the authors say. , ... (Vocus) June 15, 2010 -- A UCSF study examining the oral health of rural Hispanic ...
... <A HREF=",http://chinese.eurekalert.org/zh/emb_releases/2010-06/jaaj-hlo061110.php,">Chinese . An analysis that ... blood levels of vitamin B6 and the essential amino ... lower risk of lung cancer, including participants who were ... the June 16 issue of JAMA . ...
... food through intestine, researchers explain , TUESDAY, June 15 ... tract disorder in infants may have a genetic component, ... a birth defect that typically affects infants two to ... from the stomach into the duodenum, part of the ...
Cached Medicine News:Health News:ageet Corporation Releases GuardVox Phone to Protect IP Calls 2Health News:ageet Corporation Releases GuardVox Phone to Protect IP Calls 3Health News:ageet Corporation Releases GuardVox Phone to Protect IP Calls 4Health News:Sex, drugs and moral goals: Penn study of reproductive strategies and recreational drug use 2Health News:Sex, drugs and moral goals: Penn study of reproductive strategies and recreational drug use 3Health News:Vast geographic differences found in drug spending under Medicare 2Health News:If Mother Has Tooth Decay, Odds Increase That Child Does Too 2Health News:If Mother Has Tooth Decay, Odds Increase That Child Does Too 3Health News:Higher levels of vitamin B6, common amino acid associated with lower risk of lung cancer 2Health News:Higher levels of vitamin B6, common amino acid associated with lower risk of lung cancer 3Health News:Common Birth Defect Likely Inherited 2
For vacuum-driven processing of spin columns; Reduced sample handling and accelerated processing; Parallel sample processing using QIAGEN spin columns; Easy cleaning of internal components by simpl...
Inquire...
... allows processing of up to 24 spin columns in ... columns into and out of a centrifuge. The ... savings rapid vacuum-driven purification and cleanup of ... Convenience minimal hands-on-time ...
... Caliper provide an automated alternative to Kuderna-Danish, Rotary, Vacuum-Style and Nitrogen Blow-Down Evaporators. For over ten years ... ... ... ...
Medicine Products: